Clinical Trial

Tunlametinib in Combination With Pucotenlimab and Hydroxychloroquine in NRAS Mutant Melanoma

Recruiting Phase 2
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Summary
This study evaluates the combination of the autophagy inhibitor hydroxychloroquine (HCQ), the MEK inhibitor tunlametinib, and the anti-PD-1 antibody pucotenlimab in patients with locally advanced or metastatic melanoma. The primary objectives are to assess the objective response rate (ORR) and progression-free survival (PFS). Secondary objectives include evaluating adverse events (type, severity, and incidence), duration of response (DOR), disease control rate (DCR), and overall survival (OS), as well as exploring the molecular mechanisms by which autophagy modulation enhances immunogenicity in mutant melanoma. Further exploratory analyses will examine the mechanisms by which autophagy inhibition enhances tumor sensitivity to PD-1 blockade, thereby establishing experimental and theoretical grounds for refining future clinical approaches.
Trial Details
NCT Number NCT07750067
Lead Sponsor Sun Yat-sen University
Conditions Melanoma Metastatic, NRAS Mutation
Enrollment 37 participants
Start Date 2026-04-01
Primary Completion 2030-07-28 (estimated)
Study Completion 2030-07-28 (estimated)
Updated on ClinicalTrials.gov 2026-08-10